1. Field of the Invention
This invention relates to a new tracheostomy tube and tracheostomy system for performing percutaneous tracheostomy.
2. Description of the Related Art
Percutaneous placement of a tracheostomy is a very common procedure today. It is performed by making a small mid-line incision just over the trachea. Blunt dissection is used to separate the soft tissue down to the level of the tracheal rings. A needle is then placed between adjacent tracheal rings and a guide wire is inserted through the needle, usually under bronchoscopic guidance. Multiple dilators of increasing size or diameters are used to enlarge the ostomy to a sufficient diameter to accommodate the desired-sized tracheostomy tube. Various sizes of tracheostomy tubes are available and are selected based upon multiple factors, including but not limited to the size of the patient, the patient's clinical status such as the need for positive pressure ventilation or not, the quality and quantity of secretions, as well as the need for other medical procedures.
Typically, a larger tube is initially inserted into the patient, which is followed by insertion of successively smaller tubes as the patient improves and becomes less dependent on ventilator support. This requires multiple changes of the tube as the patient's clinical status improves. Of course, if a patient's clinical status worsens, then it is necessary to again install a larger tube. But, if a patient's clinical course worsens, it is sometimes difficult to insert the larger tube. This is because the ostomy site or tracheostoma usually closes very quickly as the soft tissue heals around the smaller tracheostomy tube, making it difficult and sometimes dangerous to remove a smaller tracheostomy tube and attempt to place a larger tube in its place.
Therefore, there is a longstanding need for a tracheostomy system which does not require the removal of the entire tracheostomy tube and its replacement whenever a different sized tube must be installed in a patient. U.S. Pat. No. 6,706,017 recognized that the use of numerous dilators in order to achieve the necessary opening for placing a tracheostomy tube is problematic. The '017 patent describes such a system as time-consuming and includes the possibility of creating tissue lesions and a false passage. Further, as described in the '017 patent, once the largest of the series of dilators is placed, the introduction of the trachea tube is often difficult because there is no protection for the tracheostomy cuff during its introduction, and this sometimes results in a rupture of the cuff. Further, such dilators are also not adapted for all the available tracheostomy tube. The solution suggested in the '017 patent is a percutaneous tracheostomy device which utilizes first and second inflatable dilators positioned about the insertion needle and insertable within the tracheostoma. The dilation device of the '017 patent is radially expandable, using a first dilator disposed about the needle and being radially expandable to provide a first degree of stoma dilation, and a second dilator disposed about the first dilator to provide a second degree of stoma dilation for the purpose of insertion of a cannula. A coiled or multiple layer sheath or tube is disposed about the dilation devices and is radially expandable in response to radial pressure from the dilation devices. After the desired diameter of expansion is achieved, the sheath is withdrawn after the cannula is placed in position. The dilator system of this '017 patent, however, is used for initial tube insertion. It does not alleviate in any way the need for frequent tube changes or the complications thereof. In addition, a one step tube insertion is not possible because the device described in the '017 patent is merely a method for inserting a commercially available, single size/type of tracheostomy tube. The device, system and method described hereinafter is not a way to simply place the well known single diameter tracheostomy tubes, but rather a new type of tracheostomy tube all together, a tube that can be made to expand and contract to various diameters depending upon desired size.